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PublicHealthOntario.ca

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http://www.publichealthontario.ca/

Let’s get visual with vaccine safety in Ontario!

Chi Yon Seo, Tara Harris

November 14, 2017

PHO Rounds


Learning objectives

2

• Describe the process and importance of vaccine safety surveillance in Ontario

• Summarize adverse events reported in Ontario following vaccines administered in 2016

• Understand the value of the vaccine safety surveillance tool in being able to readily access local and provincial vaccine safety data


Why is vaccine safety important?

3

• Public confidence in vaccine safety is critical to immunization program success

• Higher standard of safety is expected of vaccines

• Administered to large numbers of healthy people

• Low risk tolerance

• Vaccines are universally recommended, subject to “mandatory choice”

• Increased attention on safety with decreasing disease risk

• Misperception persists

© Chris Madden, 2015. Reproduced with permission.


Vaccine safety in the news

4

Robbins R. Meeting with Trump emboldens anti-vaccine activists, who see an ally in the Oval Office. Stat [Internet], 2016 Nov 30 [cited 2017 Nov 7]; Politics. Available from: https://www.statnews.com/2016/11/30/donald-trump-vaccines-policy/ Associated Press. Zuckerberg wades into vaccine debate with baby shots photo. CNBC [Internet], 2016 Jan 12 [cited 2017 Nov 7]; Health Care. Available from: https://www.cnbc.com/2016/01/12/zuckerberg-wades-into-vaccine-debate-with-baby-shots-photo.html Cohen J. France most skeptical country about vaccine safety. Science [Internet], 2016 Sep 8 [cited 2017 Nov 7]; Health. Available from: http://www.sciencemag.org/news/2016/09/france-most-skeptical-country-about-vaccine-safety Merlan A. Robert De Niro Promotes All Kinds of Anti-Vaccination Nonsense in Wild Today Interview. Jezebel [Internet], 2016 Apr 13 [cited 2017 Nov 7]. Available from: https://jezebel.com/robert-de-niro-promotes-all-kinds-of-anti-vaccination-n-1770709195

https://www.statnews.com/2016/11/30/donald-trump-vaccines-policy/








https://www.cnbc.com/2016/01/12/zuckerberg-wades-into-vaccine-debate-with-baby-shots-photo.html


















http://www.sciencemag.org/news/2016/09/france-most-skeptical-country-about-vaccine-safety














https://jezebel.com/robert-de-niro-promotes-all-kinds-of-anti-vaccination-n-1770709195























The vaccine safety system in Canada A shared responsibility

5

• Highly regulated and inspected process

• Safety monitored continuously throughout product lifecycle

• Success depends on communication and coordination across multiple stakeholders

Government of Canada. Life-cycle management [Internet]. Ottawa, ON: Government of Canada; 2007 [cited 2017 Nov 2]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/progressive-licensing/progressive-licensing-model/life-cycle-management-progressive-licensing-model-drugs-health-products.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/progressive-licensing/progressive-licensing-model/life-cycle-management-progressive-licensing-model-drugs-health-products.html































AEFI = Adverse event following immunization

6

• AEFIs can be caused by the vaccine or may occur by chance

• Includes both expected (i.e. listed in product monograph) and unexpected events

• An AEFI is not the same as side effects which are linked to a vaccine by scientific studies

An AEFI is any untoward medical occurrence that follows immunization

It does not necessarily have a causal relationship with the vaccine

The adverse event may be any unfavourable or unintended sign, laboratory finding, symptom, or disease.


Public health surveillance of vaccine safety

7

• Core component of the vaccine safety system

• Collaborative system led by Public Health Agency of Canada; all 13 P/T public health authorities participate

• Passive reporting of individual case reports (adverse events following immunization/AEFI) • Identifies rare events not detected during clinical trials

• Generates safety signals that warrant further investigation

• Informs regulatory actions, public health decision making and communication

• Other post-marketing surveillance activities support ongoing monitoring of safety (e.g., IMPACT)


Investigation

Analysis

Interpretation

Dissemination and

communication

Detection and

reporting

8

AEFI surveillance

cycle


Vaccine safety surveillance in Ontario

9

• AEFIs are identified and reported by health care providers, vaccine recipients or their caregivers

• Health care provider reporting is mandated (Health Protection and Promotion Act)

• Public health units play a central role

• Receive, assess and investigate AEFI reports

• Documentation according to provincial surveillance criteria

• Provide information, support and advice to vaccine recipients and health care providers in their community


Vaccine safety @ PHO

10

• PHO conducts provincial AEFI surveillance • Routine monitoring, annual reports, ad hoc analyses • Surveillance system documentation (i.e. case definitions, user

guides, etc.)

• Participation in national surveillance system

• Public health unit support • AEFI reporting process issues • IPHIS training and support • Advice on complex AEFIs

• Tools and resources for immunizers and health care providers who report AEFIs

• Member of WHO’s Vaccine Safety Net


Annual Report on Vaccine Safety in Ontario, 2016

11

• Released Thursday November 9 • Annual report (PDF)

• Technical annex

• Immunizer overview

• Online, interactive data tool

www.publichealthontario.ca/vaccinesafety


Annual Report on Vaccine Safety in Ontario, 2016

12

Objectives

• To summarize AEFIs reported in Ontario following vaccines administered in 2016

• To assess AEFI reporting trends over five years (2012-2016)


Methods

13

• Data extracted from the integrated Public Health Information System (iPHIS) on May 9, 2017

• Active immunizing agents only; publicly funded and non-publicly funded vaccines

• Descriptive analysis limited to “confirmed” AEFIs

• Reporting rates calculated based on population estimates/projections for overall rates and doses distributed for vaccine-specific rates

• Serious AEFIs defined using standard WHO definition adapted for use in Ontario

PublicHealthOntario.ca 14

Reporting trends, 2012-16

Number of AEFI reports and reporting rate per 100,000 population by year: Ontario, 2012-16


Age distribution, 2012-16 Annual AEFI reporting rate per 100,000 population by age group: Ontario, 2012-16

• Age range in 2016: one month to 91 years of age

• Slight majority of AEFI reports in those < 18 years compared to adults ≥18 years (52.4% vs. 47.6%)


Age and sex distribution, 2016 Number of AEFI reports and reporting rates per 100,000 population by age group and sex: Ontario, 2016

• In 2016, 65.6% of AEFI reports were female; a female predominance consistently observed in Ontario1

1. Harris T, Nair J, Fediurek J, Deeks SL. Assessment of sex-specific differences in adverse events following immunization reporting in Ontario, 2012-15. Vaccine. 2017;35(19):2600-4. Available from: http://www.sciencedirect.com/science/article/pii/S0264410X17303419

http://www.sciencedirect.com/science/article/pii/S0264410X17303419




Geographic distribution: All vaccines, 2016 Overall AEFI reporting rate per 100,000 population by public health unit: Ontario, 2016


Geographic distribution: School-based vaccines, 2016

Reporting rate per 100,000 population for AEFIs among 11-17 year olds following Men-C-ACWY, HB or HPV4 vaccine by public health unit: Ontario, 2016


Geographic distribution: Influenza vaccine, 2016

Reporting rate per 100,000 doses distributed for AEFIs following influenza vaccine by public health unit: Ontario, 2016


Reporting rates and number of AEFIs by vaccine, 2016

20

Vaccine Number of

AEFI reports

Vaccine-

specific

reporting rate

Number

of serious

reports

Vaccine-specific

serious

reporting rate

Doses

distributed

Infant and childhood vaccines

DTaP-IPV-Hib 67 11.7 10 1.7 574,321

Pneu-C-13 49 10.3 8 1.7 476,535

Rot-1 24 9.1 4 1.5 264,617

Men-C-C 21 10.1 2 1.0 207,992

MMR 37 13.5 2 0.7 274,688

Var 56 25.3 2 0.9 221,113

MMRV 18 10.4 0 0.0 173,828

Tdap-IPV 26 10.8 1 0.4 240,867

Adolescent vaccines

Men-C-ACWY 38 20.8 2 1.1 182,604

HB 69 26.9 2 0.8 256,264

HPV4 69 32.9 1 0.5 209,474

Tdap 65 8.1 0 0.0 804,844

Routine adult vaccines

Pneu-P-23 66 27.8 0 0.0 237,535

Td 7 3.4 0 0.0 203,574

Universal Influenza Immunization Program (UIIP)

Inf 120 3.3 4 0.1 3,603,830


Number of serious and non-serious AEFI reports by adverse event category: Ontario, 2016

21

Serious AEFIs

Systemic events

Injection site

reactions

Allergic events

Other

severe/unusual

events

Neurological

events

0 50 100 150 200 250

Other severe/unusual events

Myelitis

Guillian-Barré Syndrome

Bell's palsy

Convulsions/seizure

Anaesthesia/paraesthesia

Oculorespiratory syndrome

Event managed as anaphylaxis

Allergic reaction - skin

Parotitis

Intussusception

Thrombocytopenia

Hypotonic-hyporesponsive episode

Persistent crying/screaming

Arthritis/arthralgia

Adenopathy/lymphadenopathy

Syncope with injury

Severe vomiting/diarrhea

Fever

Rash

Sterile abscess

Infected abscess

Nodule

Cellulitis

Pain/redness/swelling

Number of reports

Ad

vers

e e

ven

t


Specific adverse events

22

• Injection site reactions

• Most frequently reported (48.7% of all reports)

• Most frequently associated vaccines: Pneu-P-23 and Var

• Rash

• Second most frequent reported event (22.1% of reports)

• 41.0% associated with live virus vaccines

• 3 confirmed vaccine-strain virus by genotyping (2 measles, 1 varicella-zoster)

• Anaphylaxis

• 8 reports; 1.0 per million doses distributed

• 6 met Brighton definition (four level I, two level II diagnostic certainty)


Serious AEFIs

23

• 19 serious AEFIs (3.0% of reports)

• Reporting rate of 1.4 per million population or 2.3 per million doses distributed

• 89.5% (n=17) < 18 years, with most < 4 years (n=15)

• 42.1% (n=8) documented as reported by IMPACT

• 21.1% (n=4) documented to have been referred to the Special Immunization Clinic (SIC) network


Serious AEFIs

24

• All hospitalized, mean length of stay of 4.0 days

• Febrile illness (n=12) was the most frequently reported event

• 11 in children <10 years

• Includes 3 reports of Kawasaki disease

• One report of death in 2016 in an elderly adult

• Immune compromising medications, received zoster vaccine

• Live vaccines, including zoster vaccine are contraindicated in immunocompromised persons and persons on immune compromising medications


Summary

25

• Overall, low rate of AEFI reporting in Ontario with no unexpected vaccine safety issues

• Most commonly reported events were mild; serious events were very rare

• Ongoing surveillance of AEFIs in Ontario is needed to monitor vaccine safety and to develop strategies to address under-reporting within the surveillance system


Online vaccine safety surveillance tool

26

• Online, interactive tool allows users to explore, manipulate and download vaccine safety data

• Inform decision-making by public health practitioners

• Support health professional communication about vaccine safety

• Initial design and usability testing conducted in consultation with public health stakeholders

• Updated annually for enhanced functionality and usability


Vaccine safety surveillance tool

www.publichealthontario.ca/vaccinesafety

http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/Pages/Vaccine-Safety.aspx


Next steps

28

• Continue to develop online resources including the interactive data tool

• Further collaboration with PHUs and MOHLTC to develop strategies to address underreporting of AEFIs

• Engage system stakeholders and encourage continued AEFI reporting

Suggestions and feedback on our products and resources?

Contact us: [email protected]

mailto:[email protected]


AEFI REPORTING IN 3 STEPS

29


Acknowledgements

30

• Shelley Deeks • Kelty Hillier • Jody Stapleton • Jyotsna Nair • Bryna Warshawsky • Jodi Gatley • LeeAnn Desa

• Brenda Lee • Alex Dunaevsky • Kate Curzon • Stacie Carey • Lucia Zdeb • Steven Johnson

• Vaccine safety surveillance tool usability testers

• All the PHU and MOHLTC staff involved in Vaccine Safety Surveillance in Ontario


Date: Wednesday, November 15, 2017 Location: DoubleTree by Hilton, Downtown Toronto Webinar option available Visit ‘Upcoming Events’ Page : www.publichealthontario.ca

Vaccine Sciences Symposium 2017

http://www.publichealthontario.ca/


Questions

32


Extra slides

33

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